Amgen Senior Associate Quality Control - Swing Shift 2PM-11PM in Thousand Oaks, California

The Sr. Associate Quality Control will primarily support the QC Microbiology and Analytical Chemistry Laboratories by performing testing and data review/approval for time sensitive assays such as Bioburden testing, PCR (Mycoplasma and Minute Mouse Virus), Biological Indicators and HPLC. You may support testing for additional Microbiology and Chemistry related assays. The Sr. Associate will also perform sample management activities such as sample processing and sample pick up at the various Manufacturing buildings.

Candidates interested in this position are will work a swing shift (2pm-11pm) which will include one weekend day (Tuesday-Saturday shift or Sunday-Thursday shift).

Key Responsibilities:

Perform analytical testing in accordance with established Analytical Methods and Standard Operating Procedures

Report, evaluate, trend and approve analytical data

Troubleshoot, solve problems and communicate with stakeholders

Respond to Critical Equipment Monitoring System alarms

Generate complete, accurate, and concise documentation using electronic systems and laboratory notebooks

Participate in audits, initiatives, and projects that may be departmental or organizational in scope

Evaluate lab practices for compliance and operational excellence improvement on a continuous basis

Participate in lab investigations

Conduct training for new and existing staff

May represent the department/organization on various teams

Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of Quality Control experience

OR

Associate's degree and 6 years of Quality Control experience

OR

High school diploma / GED and 8 years of Quality Control experience

Preferred Qualifications

cGMP Experience

Experience with Microbiology testing techniques such as Membrane Filtration

Experience and training in aseptic technique

Experience with Polymerase Chain Reaction

Experience using Laboratory Information Management Systems

Experience using Waters H-Class UHPLC and Agilent HPLC instrumentation

Experience using Chromatography Data Systems, such as Empower

Experience and knowledge of Data Integrity Requirements of QC Systems

Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)

Excellent problem-solving capabilities and attention to detail

Experience of collaboration within and across functional areas and outstanding customer service focus

Excellent written and verbal communication skills

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.